Dong Shuang, Ou Wuling, Zhong Yi, Zhu Xianmin, Cai Qian, Zhang Jing, Ran Fengming, Qian Yu, Wang Jun, Hu Sheng
Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Ann Transl Med. 2022 Jan;10(2):101. doi: 10.21037/atm-22-79.
The outcomes of advanced non-small cell lung cancer (NSCLC) patients after first- or second-line therapy are still discouraging due to a lack of effective treatment strategies. As a novel oral anti-angiogenesis drug, apatinib, approved by the National Medical Products Administration of China only for advanced gastric cancer, has been increasingly used in off-label treatment across various cancer types in recent years, especially advanced NSCLC. It has shown strong anti-tumor efficacy and acceptable safety.
This prospective study (NCT02974933) was conducted in patients with advanced NSCLC, who had suffered disease progression from the first- or second-line treatment, in Hubei Cancer Hospital. Eligible patients were enrolled and administrated with apatinib mesylate (500 mg qd) in combination with pemetrexed (500 mg/m, every 4 weeks). The primary endpoint was progression-free survival (PFS).
From September 2016 to September 2019, a total of 21 advanced NSCLC patients were enrolled in Hubei Cancer Hospital. As of January 2021, treatment was discontinued in all patients, with 1 still in follow-up. There were 7/21 (33.3%) patients who achieved objective response. The median PFS and median overall survival (OS) were 7.0 months (95% CI: 6.15-7.85 months) and 13.0 months (95% CI: 7.39-18.6 months), respectively. Toxicities were tolerable or could be clinically managed. The most common grade 3-4 adverse events (AEs) were hypertension (14.3%, 3/21), hand-foot syndrome (4.7%, 1/21), and proteinuria (4.7%, 1/21). Hematological toxicities were moderate, with rare occurrences of grade 3/4 toxicities. During the period of treatment, there was no occurrence of treatment-related death.
Apatinib plus pemetrexed demonstrated promising efficacy and a high level of safety profile in previously heavily-treated NSCLC patients. More definitive studies on the combination of apatinib and pemetrexed are warranted.
由于缺乏有效的治疗策略，晚期非小细胞肺癌（NSCLC）患者一线或二线治疗后的结局仍然令人沮丧。作为一种新型口服抗血管生成药物，阿帕替尼仅被中国国家药品监督管理局批准用于晚期胃癌，但近年来已越来越多地用于各种癌症类型的超适应症治疗，尤其是晚期NSCLC。它已显示出强大的抗肿瘤疗效和可接受的安全性。
这项前瞻性研究（NCT02974933）在湖北省肿瘤医院对一线或二线治疗后病情进展的晚期NSCLC患者中进行。符合条件的患者入组并接受甲磺酸阿帕替尼（500mg，每日一次）联合培美曲塞（500mg/m²，每4周一次）治疗。主要终点是无进展生存期（PFS）。
2016年9月至2019年9月，湖北省肿瘤医院共纳入21例晚期NSCLC患者。截至2021年1月，所有患者均停止治疗，1例仍在随访中。有7/21（33.3%）的患者获得客观缓解。中位PFS和中位总生存期（OS）分别为7.0个月（95%CI：6.15 - 7.85个月）和13.0个月（95%CI：7.39 - 18.6个月）。毒性是可耐受的或可在临床上进行处理。最常见的3 - 4级不良事件（AE）为高血压（14.3%，3/21）、手足综合征（4.7%，1/21）和蛋白尿（4.7%，1/21）。血液学毒性为中度，3/4级毒性罕见。在治疗期间，未发生与治疗相关的死亡。
阿帕替尼联合培美曲塞在既往接受过大量治疗的NSCLC患者中显示出有前景的疗效和较高的安全性。有必要对阿帕替尼和培美曲塞的联合进行更确切的研究。
